The Drugs Consultative Committee (DCC) has agreed to amend the Drugs Rules, 1945, to include Good Distribution Practices (GDP) for pharmaceutical products as a separate schedule. This follows a detailed consultation process with industry stakeholders and aligns with the revised World Health Organization (WHO) Technical Report Series (TRS) guidelines.

The proposal was initially discussed in the DCC meeting held in January 2024, where the committee noted that the non-mandatory nature of current GDP guidelines had led to inconsistent drug storage and handling practices across the supply chain. Recognizing this as a potential risk to drug quality and patient safety, the committee recommended revising the guidelines in line with WHO standards and giving them legal backing by incorporating them into the Drugs Rules.

A stakeholder consultation was subsequently conducted, and feedback received from industry representatives was reviewed in a recent DCC meeting. Based on these discussions, the committee formally agreed to proceed with the amendment.

The move comes in response to persistent industry concerns over inadequate regulation of drug transportation and storage. These factors, if not properly controlled, can compromise the quality and efficacy of pharmaceutical products—issues that ultimately affect manufacturers’ accountability.

The Parliamentary Standing Committee on Chemicals and Fertilisers had also recommended earlier this year that the Department of Pharmaceuticals (DoP) make GDP legally enforceable as a deterrent against the proliferation of substandard and spurious drugs in the country.

This long-standing issue was previously deliberated during the DCC’s 54th meeting in July 2018, when CDSCO drafted initial GDP guidelines and sought public input. The current effort represents a major step toward formalising those guidelines into enforceable legal provisions, ensuring uniformity in distribution and storage practices nationwide.